102910 Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to 5 U.S.C. 1009(d), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended, and the Determination of 

the Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention, pursuant to Public Law 92– 

463. The grant applications and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

RFA–OH–25–003, Occupational Safety 

and Health Training Project Grants 

(TPG). 

Date: March 4, 2025. 

Time: 12:00 p.m.–5:00 p.m., EST. 

Place: Video-Assisted Meeting. 

Agenda: To review and evaluate grant 

applications. 

For Further Information Contact: 

Marilyn Ridenour, B.S.N., M.P.H., 

Scientific Review Officer, Office of 

Extramural Programs, National Institute 

for Occupational Safety and Health, 

Centers for Disease Control and 

Prevention, 1095 Willowdale Road, 

Morgantown, West Virginia 26505. 

Telephone: (304) 285–5879; Email: 

MRidenour@cdc.gov. 

The Director, Office of Strategic 

Business Initiatives, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2024–30022 Filed 12–17–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to 5 U.S.C. 1009(d), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended, and the Determination of 

the Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention, pursuant to Public Law 92– 

463. The grant applications and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

PAR 18–812, NIOSH Member Conflict 

Review. 

Date: February 6, 2025. 

Time: 1 p.m.–3 p.m., EST. 

Place: Teleconference. 

Agenda: To review and evaluate grant 

applications. 

For Further Information Contact: 

Michael Goldcamp, Ph.D., Scientific 

Review Officer, Office of Extramural 

Programs, National Institute for 

Occupational Safety and Health, Centers 

for Disease Control and Prevention, 

1095 Willowdale Road, Morgantown, 

West Virginia 26505. Telephone: (304) 

285–5951; Email: MGoldcamp@cdc.gov. 

The Director, Office of Strategic 

Business Initiatives, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2024–30021 Filed 12–17–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–2844] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Reclassification 

Petitions for Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 17, 

2025. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0138. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Reclassification Petitions for Medical 

Devices 

OMB Control Number 0910–0138— 

Extension 

This information collection helps 

support implementation of statutory 

provisions found in sections 513(e) and 

(f), 514(b), 515(b), and 520(l) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360c(e) and (f), 21 

U.S.C. 360d(b), 21 U.S.C. 360e((b), and 

21 U.S.C. 360j(l)) pertaining to the 

reclassification of medical devices. 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices 102911 

Specifically, the FD&C Act establishes 

three tiers of regulatory control for 

medical devices, by establishing three 

classes of medical devices, and 

requiring that all devices be classified 

into one of these three classes. The 

classification of a device depends upon 

the degree of regulatory control 

necessary to provide a reasonable 

assurance of the safety and effectiveness 

of the device. The three tiers of 

regulatory control are: (1) Class I— 

general controls, subject to sections 501 

adulteration, 502 misbranding, 510 

registration, 516 banned devices, 518 

notification and other remedies, 519 

records and reports, and 520 general 

provisions of the FD&C Act; (2) Class 

II—performance standards; and (3) Class 

III—premarket approval. 

Implementing regulations in 21 CFR 

part 860, subpart C (parts 860.120 

through 860.136) provide that any 

person may petition for reclassification 

of a device from any class to any other 

class and prescribe requisite format and 

content elements for reclassification 

petitions submitted to the Agency. We 

also provide information on our website 

at https://www.fda.gov/about-fda/cdrhtransparency/reclassification regarding 

medical device reclassification, which 

may serve as a helpful resource to 

respondents. 

FDA is responsible for reviewing 

petitions for reclassification and 

determining whether the subject device 

will be reclassified. In some instances, 

FDA also submits such petitions to one 

of its medical device advisory panels for 

review and recommendations. FDA’s 

decision regarding the reclassification of 

a device is based primarily upon the 

information contained in the petition. 

Respondents to the information 

collection are private sector, for-profit 

businesses. We have not identified 

reclassification petitions as a type of 

submission we are currently prepared to 

accept electronically. Submission 

instructions, including addresses, are 

provided in § 860.123(b). 

In the Federal Register of July 9, 2024 

(89 FR 56390), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

One comment was received, but it was 

not related to this information 

collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total 

hours 

§ 860.123; supporting data for reclassification petitions ..... 12 1 12 497 5,964 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Reclassification petitions must be 

submitted as set forth in the applicable 

regulations, which provide for the 

submission of an original and two 

copies (§ 860.123(b)(4)). Each petition 

must include supporting data to show 

why reclassification of the device type 

will provide reasonable assurance of the 

safety and effectiveness of the device 

type. The principal data in such a 

petition will typically be reports of 

clinical trials. 

Our estimated burden for the 

information collection reflects an 

increase of 6 responses and a 

corresponding increase of 2,982 hours. 

We attribute this adjustment to an 

increase in the number of submissions 

we received over the last few years. 

Dated: December 11, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–29955 Filed 12–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4974] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Advanced 

Manufacturing Technologies 

Designation Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 17, 

2025. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0139. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Advanced Manufacturing Technologies 

Designation Program 

OMB Control Number 0910–0139— 

Revision 

This information collection supports 

the establishment of an FDA Advanced 

Manufacturing Technologies (AMT) 

Designation Program, as provided for in 

section 506L of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

356l). Intending to enhance the 

development of and combat the shortage 

of critical medical products, the AMT 

Designation Program encourages early 

adoption of new technological advances 

in manufacturing processes by the 

pharmaceutical industry or other drug/ 


khammond on DSK9W7S144PROD with NOTICES